Renal Dialysis Equipment Pipeline by Stages of Development, Segments, Region, Regulatory Path and Key Companies

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Renal Dialysis Equipment Pipeline Market Report Overview

Renal dialysis equipment is intended to provide an artificial replacement for lost kidney function due to renal failure. Dialysis machines, dialysis accessories, vascular access devices for hemodialysis, and stone management disposables are covered in this category.

The renal dialysis equipment pipeline market research report provides comprehensive information about the renal dialysis equipment pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

Key Segments Dialysis Accessories, Grafts, Hemodialysis Machines, Hemodialysis Catheters, and Peritoneal Dialysis Equipment
Key Territories The US, Europe, China, Australia, India, Japan, New Zealand, Israel, Canada, Singapore, South Korea, Taiwan, United Kingdom, Chile, and Brazil
Key Regulatory Paths 510(k), CE, NMPA, PMA, TGA, Ninsho, ICAC, HSA, MDL, BOPA, MDITAC, de novo, BLA, UKCA, ANVISA, and HDE Approvals
Leading Companies Access Vascular Inc, Baxter International Inc, Byonyks, Chrysalis Medical Inc, CVS Kidney Care, Diality Inc, Diavantis, Infomed SA, Kuleana Technology Inc, Nicast Ltd, and Nipro Corp
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Renal Dialysis Equipment Pipeline Market Segments

The renal dialysis equipment market segments are dialysis accessories, grafts, hemodialysis machines, hemodialysis catheters, and peritoneal dialysis equipment among others. In 2023, dialysis accessories segment had the largest products in pipeline.

Renal Dialysis Equipment Pipeline Market Analysis by Segments, 2023 (%)

Renal Dialysis Equipment Pipeline Market Analysis by Segments, 2023 (%)

For more segment-wise insights on the renal dialysis equipment pipeline market, download a free sample report

Renal Dialysis Equipment Pipeline Market Segmentation by Territories

Some of the territories in the renal dialysis equipment market are the United States, Europe, China, Australia, India, Japan, New Zealand, Israel, Canada, Singapore, South Korea, Taiwan, United Kingdom, Chile, and Brazil among others. As of June 2023, the United States had the highest number of pipeline products.

Renal Dialysis Equipment Pipeline Market Analysis, by Territories, 2023 (%)

Renal Dialysis Equipment Pipeline Market Analysis, by Territories, 2023 (%)

For more territory insights into the renal dialysis equipment pipeline market, download a free report sample

Renal Dialysis Equipment Pipeline Market Segmentation by Regulatory Paths

Some of the regulatory paths in the renal dialysis equipment pipeline market are 510(k), CE, NMPA, PMA, TGA, Ninsho, ICAC, HAS, MDL, BOPA, de novo, HDE Approvals, BLA, and UKCA among others. As of June 2023, 510(k) was the most followed pathway for pipeline products.

Renal dialysis equipment Pipeline Market Analysis, by Regulatory Paths, 2023 (%)

Renal dialysis equipment Pipeline Market Analysis, by Regulatory Paths, 2023 (%)

For more regulatory path insights into the renal dialysis equipment pipeline market, download a free report sample

Renal Dialysis Equipment Pipeline Market – Competitive Landscape

Some of the key companies in the renal dialysis equipment pipeline market are Access Vascular Inc, Baxter International Inc, Byonyks, Chrysalis Medical Inc, CVS Kidney Care, Diality Inc, Diavantis, Infomed SA, Kuleana Technology Inc, Nicast Ltd, and Nipro Corp among others.

Access Vascular Inc: Access Vascular Inc (Access Vascular) develops and manufactures hydrogel-based devices. The company’s devices use hydrogel-based biomaterial to reduce the body’s thrombotic response and subsequent clinical complications. Access Vascular is headquartered in Bedford, Massachusetts, the US.

Segments Covered in the Report

Renal Dialysis Equipment Pipeline Market Territories Outlook

  • The US
  • The United Kingdom
  • Europe
  • China
  • Australia
  • India

Renal Dialysis Equipment Pipeline Market Regulatory Paths Outlook

  • 510(k)
  • CE
  • NMPA
  • PMA
  • TGA
  • Ninsho
  • ICAC
  • HAS

Scope

  • Extensive coverage of the renal dialysis equipment under development
  • Reviews details of major pipeline products which include, product description, licensing and collaboration details, and other developmental activities
  • Reviews the major players involved in the development of renal dialysis equipment and list all their pipeline projects
  • The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage
  • The report provides key clinical trial data of ongoing trials specific to pipeline products
  • Recent developments in the segment/industry

Reasons to Buy

The report enables you to:

  • Formulate significant competitor information, analysis, and insights to improve R&D strategies
  • Identify emerging players with the potentially strong product portfolios and create effective counter strategies to gain a competitive advantage
  • Identify and understand important and diverse types of renal dialysis equipment under development
  • Develop market-entry and market-expansion strategies
  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline
  • In-depth analysis of the product’s current stage of development, territory, and estimated launch date

Access Vascular Inc
Acotec Scientific Holdings Ltd
Advanced Dialysis Methods Ltd.
Advent Access Pte Ltd
AngioDynamics Inc
Angiotech Pharmaceuticals Inc
Aperture Biomedical LLC
Ariste Medical LLC
Ash Access Technology Inc
Baxter International Inc
Biosurfaces Inc
Bioteque Corp
BOA Biomedical Inc
Brookhaven Medical Inc
Byonyks
CatheNect Medical
Cerovations LLC
Chemica Technologies Inc
Chrysalis Medical Inc
Columbia University
CR Bard Inc
CVS Kidney Care
Cytograft Tissue Engineering Inc (Inactive)
Debiotech SA
Dialco Medical Inc
Diality Inc
Diavantis
Districlass Medical SA
Ellen Medical Devices Pty Ltd
Emory University
Eqalix, Inc.
ExThera Medical Corp
Fistulink Ltd.
Fresenius Medical Care Holdings Inc
Gambro Dasco SpA
Georgia Institute of Technology
Glomeria Therapeutics srl
Haemair Ltd
Healionics Corporation
Hemotek Medical Inc
Humacyte Inc
Indian Institute of Technology Bombay
Infomed SA
InnAVasc Medical Inc
Innovative BioTherapies Inc
Katharos, Inc.
Koronis Biomedical Technologies Corporation
Kuleana Technology Inc
Laminate Medical Technologies Ltd
LiberDi Ltd
Mar Cor Purification Inc
Marvao Medical Devices Ltd
Minnesota Health Solutions Corporation
Mozarc Medical Holding LLC
Nanodialysis BV
NanoVasc, Inc.
Neokidney Development BV
Nephros Inc
Nicast Ltd
Nikkiso Co Ltd
Nipro Corp
Northwestern University
Novaflux Technologies
NuVascular Technologies Inc
NxStage Medical Inc
Occlutech International AB
Oxford Biomaterials Ltd
Padmaseetha Technologies Pvt Ltd
Phase One Medical LLC
Phraxis, Inc.
Physiologas Technologies Inc
Qidni Labs Inc
Quanta Dialysis Technologies Ltd
Rajamadhangi Medical Technologies Pvt Ltd
Rambam Health Care Campus
Redsense Medical AB
RegenMedTX LLC
Renal Solutions Inc
SeaStar Medical
Senexis Limited (Inactive)
Shandong Weigao Blood Purification Products Co Ltd
Silmag SA
Simergent LLC
Southern Illinois University Carbondale
Specialty Renal Products Inc
Stent Tek Ltd
TEI Biosciences Inc
Thorn Technologies LLC
Triomed AB
University of Arizona
University of California
University of California San Francisco
University of Colorado
University of Limerick
University of Michigan
University of Rochester
University of Texas Southwestern Medical Center
University of Toledo
University of Vermont
Vanderbilt University
Vascoscope BV
Vascudyne Inc
Vascular Genesis
Verasonics, Inc.
Vital Access Corp
Vizio Medical Devices
Voyager Biomedical Inc
Xeltis AG
Xerem Medical Ltd
Zylox-Tonbridge Medical Technology Co Ltd

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 10

|1.2 List of Figures 20

2 Introduction 21

2.1 Renal Dialysis Equipment Overview 21

3 Products under Development 23

3.1 Renal Dialysis Equipment – Pipeline Products by Stage of Development 23

3.2 Renal Dialysis Equipment – Pipeline Products by Segment 24

3.3 Renal Dialysis Equipment – Pipeline Products by Territory 25

3.4 Renal Dialysis Equipment – Pipeline Products by Regulatory Path 27

3.5 Renal Dialysis Equipment – Pipeline Products by Estimated Approval Date 28

3.6 Renal Dialysis Equipment – Ongoing Clinical Trials 29

4 Renal Dialysis Equipment – Pipeline Products under Development by Companies 30

4.1 Renal Dialysis Equipment Companies – Pipeline Products by Stage of Development 30

4.2 Renal Dialysis Equipment – Pipeline Products by Stage of Development 34

5 Renal Dialysis Equipment Companies and Product Overview 38

5.1 Access Vascular Inc Company Overview 38

5.1.1 Access Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 38

5.2 Acotec Scientific Holdings Ltd Company Overview 40

5.2.1 Acotec Scientific Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 40

5.3 Advanced Dialysis Methods Ltd. Company Overview 41

5.3.1 Advanced Dialysis Methods Ltd. Pipeline Products & Ongoing Clinical Trials Overview 41

5.4 Advent Access Pte Ltd Company Overview 42

5.4.1 Advent Access Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 42

5.5 AngioDynamics Inc Company Overview 43

5.5.1 AngioDynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.6 Angiotech Pharmaceuticals Inc Company Overview 45

5.6.1 Angiotech Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 45

5.7 Aperture Biomedical LLC Company Overview 46

5.7.1 Aperture Biomedical LLC Pipeline Products & Ongoing Clinical Trials Overview 46

5.8 Ariste Medical LLC Company Overview 47

5.8.1 Ariste Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 47

5.9 Ash Access Technology Inc Company Overview 48

5.9.1 Ash Access Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 48

5.10 Baxter International Inc Company Overview 50

5.10.1 Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 50

5.11 Biosurfaces Inc Company Overview 63

5.11.1 Biosurfaces Inc Pipeline Products & Ongoing Clinical Trials Overview 63

5.12 Bioteque Corp Company Overview 64

5.12.1 Bioteque Corp Pipeline Products & Ongoing Clinical Trials Overview 64

5.13 BOA Biomedical Inc Company Overview 65

5.13.1 BOA Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 65

5.14 Brookhaven Medical Inc Company Overview 68

5.14.1 Brookhaven Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 68

5.15 Byonyks Company Overview 69

5.15.1 Byonyks Pipeline Products & Ongoing Clinical Trials Overview 69

5.16 CatheNect Medical Company Overview 70

5.16.1 CatheNect Medical Pipeline Products & Ongoing Clinical Trials Overview 70

5.17 Cerovations LLC Company Overview 71

5.17.1 Cerovations LLC Pipeline Products & Ongoing Clinical Trials Overview 71

5.18 Chemica Technologies Inc Company Overview 72

5.18.1 Chemica Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 72

5.19 Chrysalis Medical Inc Company Overview 73

5.19.1 Chrysalis Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 73

5.20 Columbia University Company Overview 74

5.20.1 Columbia University Pipeline Products & Ongoing Clinical Trials Overview 74

5.21 CR Bard Inc Company Overview 75

5.21.1 CR Bard Inc Pipeline Products & Ongoing Clinical Trials Overview 75

5.22 CVS Kidney Care Company Overview 76

5.22.1 CVS Kidney Care Pipeline Products & Ongoing Clinical Trials Overview 76

5.23 Cytograft Tissue Engineering Inc (Inactive) Company Overview 79

5.23.1 Cytograft Tissue Engineering Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 79

5.24 Debiotech SA Company Overview 80

5.24.1 Debiotech SA Pipeline Products & Ongoing Clinical Trials Overview 80

5.25 Dialco Medical Inc Company Overview 82

5.25.1 Dialco Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 82

5.26 Diality Inc Company Overview 83

5.26.1 Diality Inc Pipeline Products & Ongoing Clinical Trials Overview 83

5.27 Diavantis Company Overview 84

5.27.1 Diavantis Pipeline Products & Ongoing Clinical Trials Overview 84

5.28 Districlass Medical SA Company Overview 85

5.28.1 Districlass Medical SA Pipeline Products & Ongoing Clinical Trials Overview 85

5.29 Ellen Medical Devices Pty Ltd Company Overview 86

5.29.1 Ellen Medical Devices Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 86

5.30 Emory University Company Overview 89

5.30.1 Emory University Pipeline Products & Ongoing Clinical Trials Overview 89

5.31 Eqalix, Inc. Company Overview 90

5.31.1 Eqalix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 90

5.32 ExThera Medical Corp Company Overview 91

5.32.1 ExThera Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 91

5.33 Fistulink Ltd. Company Overview 92

5.33.1 Fistulink Ltd. Pipeline Products & Ongoing Clinical Trials Overview 92

5.34 Fresenius Medical Care Holdings Inc Company Overview 93

5.34.1 Fresenius Medical Care Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 93

5.35 Gambro Dasco SpA Company Overview 96

5.35.1 Gambro Dasco SpA Pipeline Products & Ongoing Clinical Trials Overview 96

5.36 Georgia Institute of Technology Company Overview 97

5.36.1 Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 97

5.37 Glomeria Therapeutics srl Company Overview 99

5.37.1 Glomeria Therapeutics srl Pipeline Products & Ongoing Clinical Trials Overview 99

5.38 Haemair Ltd Company Overview 101

5.38.1 Haemair Ltd Pipeline Products & Ongoing Clinical Trials Overview 101

5.39 Healionics Corporation Company Overview 102

5.39.1 Healionics Corporation Pipeline Products & Ongoing Clinical Trials Overview 102

5.40 Hemotek Medical Inc Company Overview 105

5.40.1 Hemotek Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 105

5.41 Humacyte Inc Company Overview 106

5.41.1 Humacyte Inc Pipeline Products & Ongoing Clinical Trials Overview 106

5.42 Indian Institute of Technology Bombay Company Overview 111

5.42.1 Indian Institute of Technology Bombay Pipeline Products & Ongoing Clinical Trials Overview 111

5.43 Infomed SA Company Overview 112

5.43.1 Infomed SA Pipeline Products & Ongoing Clinical Trials Overview 112

5.44 InnAVasc Medical Inc Company Overview 116

5.44.1 InnAVasc Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 116

5.45 Innovative BioTherapies Inc Company Overview 119

5.45.1 Innovative BioTherapies Inc Pipeline Products & Ongoing Clinical Trials Overview 119

5.46 Katharos, Inc. Company Overview 121

5.46.1 Katharos, Inc. Pipeline Products & Ongoing Clinical Trials Overview 121

5.47 Koronis Biomedical Technologies Corporation Company Overview 122

5.47.1 Koronis Biomedical Technologies Corporation Pipeline Products & Ongoing Clinical Trials Overview 122

5.48 Kuleana Technology Inc Company Overview 123

5.48.1 Kuleana Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 123

5.49 Laminate Medical Technologies Ltd Company Overview 124

5.49.1 Laminate Medical Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 124

5.50 LiberDi Ltd Company Overview 128

5.50.1 LiberDi Ltd Pipeline Products & Ongoing Clinical Trials Overview 128

5.51 Mar Cor Purification Inc Company Overview 131

5.51.1 Mar Cor Purification Inc Pipeline Products & Ongoing Clinical Trials Overview 131

5.52 Marvao Medical Devices Ltd Company Overview 132

5.52.1 Marvao Medical Devices Ltd Pipeline Products & Ongoing Clinical Trials Overview 132

5.53 Minnesota Health Solutions Corporation Company Overview 133

5.53.1 Minnesota Health Solutions Corporation Pipeline Products & Ongoing Clinical Trials Overview 133

5.54 Mozarc Medical Holding LLC Company Overview 134

5.54.1 Mozarc Medical Holding LLC Pipeline Products & Ongoing Clinical Trials Overview 134

5.55 Nanodialysis BV Company Overview 136

5.55.1 Nanodialysis BV Pipeline Products & Ongoing Clinical Trials Overview 136

5.56 NanoVasc, Inc. Company Overview 137

5.56.1 NanoVasc, Inc. Pipeline Products & Ongoing Clinical Trials Overview 137

5.57 Neokidney Development BV Company Overview 138

5.57.1 Neokidney Development BV Pipeline Products & Ongoing Clinical Trials Overview 138

5.58 Nephros Inc Company Overview 139

5.58.1 Nephros Inc Pipeline Products & Ongoing Clinical Trials Overview 139

5.59 Nicast Ltd Company Overview 140

5.59.1 Nicast Ltd Pipeline Products & Ongoing Clinical Trials Overview 140

5.60 Nikkiso Co Ltd Company Overview 141

5.60.1 Nikkiso Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 141

5.61 Nipro Corp Company Overview 144

5.61.1 Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 144

5.62 Northwestern University Company Overview 145

5.62.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 145

5.63 Novaflux Technologies Company Overview 147

5.63.1 Novaflux Technologies Pipeline Products & Ongoing Clinical Trials Overview 147

5.64 NuVascular Technologies Inc Company Overview 148

5.64.1 NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 148

5.65 NxStage Medical Inc Company Overview 150

5.65.1 NxStage Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 150

5.66 Occlutech International AB Company Overview 152

5.66.1 Occlutech International AB Pipeline Products & Ongoing Clinical Trials Overview 152

5.67 Oxford Biomaterials Ltd Company Overview 153

5.67.1 Oxford Biomaterials Ltd Pipeline Products & Ongoing Clinical Trials Overview 153

5.68 Padmaseetha Technologies Pvt Ltd Company Overview 154

5.68.1 Padmaseetha Technologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 154

5.69 Phase One Medical LLC Company Overview 155

5.69.1 Phase One Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 155

5.70 Phraxis, Inc. Company Overview 157

5.70.1 Phraxis, Inc. Pipeline Products & Ongoing Clinical Trials Overview 157

5.71 Physiologas Technologies Inc Company Overview 158

5.71.1 Physiologas Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 158

5.72 Qidni Labs Inc Company Overview 159

5.72.1 Qidni Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 159

5.73 Quanta Dialysis Technologies Ltd Company Overview 160

5.73.1 Quanta Dialysis Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 160

5.74 Rajamadhangi Medical Technologies Pvt Ltd Company Overview 161

5.74.1 Rajamadhangi Medical Technologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 161

5.75 Rambam Health Care Campus Company Overview 162

5.75.1 Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 162

5.76 Redsense Medical AB Company Overview 163

5.76.1 Redsense Medical AB Pipeline Products & Ongoing Clinical Trials Overview 163

5.77 RegenMedTX LLC Company Overview 164

5.77.1 RegenMedTX LLC Pipeline Products & Ongoing Clinical Trials Overview 164

5.78 Renal Solutions Inc Company Overview 165

5.78.1 Renal Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 165

5.79 SeaStar Medical Company Overview 166

5.79.1 SeaStar Medical Pipeline Products & Ongoing Clinical Trials Overview 166

5.80 Senexis Limited (Inactive) Company Overview 173

5.80.1 Senexis Limited (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 173

5.81 Shandong Weigao Blood Purification Products Co Ltd Company Overview 174

5.81.1 Shandong Weigao Blood Purification Products Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 174

5.82 Silmag SA Company Overview 181

5.82.1 Silmag SA Pipeline Products & Ongoing Clinical Trials Overview 181

5.83 Simergent LLC Company Overview 183

5.83.1 Simergent LLC Pipeline Products & Ongoing Clinical Trials Overview 183

5.84 Southern Illinois University Carbondale Company Overview 186

5.84.1 Southern Illinois University Carbondale Pipeline Products & Ongoing Clinical Trials Overview 186

5.85 Specialty Renal Products Inc Company Overview 187

5.85.1 Specialty Renal Products Inc Pipeline Products & Ongoing Clinical Trials Overview 187

5.86 Stent Tek Ltd Company Overview 189

5.86.1 Stent Tek Ltd Pipeline Products & Ongoing Clinical Trials Overview 189

5.87 TEI Biosciences Inc Company Overview 190

5.87.1 TEI Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 190

5.88 Thorn Technologies LLC Company Overview 191

5.88.1 Thorn Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 191

5.89 Triomed AB Company Overview 192

5.89.1 Triomed AB Pipeline Products & Ongoing Clinical Trials Overview 192

5.90 University of Arizona Company Overview 196

5.90.1 University of Arizona Pipeline Products & Ongoing Clinical Trials Overview 196

5.91 University of California Company Overview 197

5.91.1 University of California Pipeline Products & Ongoing Clinical Trials Overview 197

5.92 University of California San Francisco Company Overview 198

5.92.1 University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 198

5.93 University of Colorado Company Overview 200

5.93.1 University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 200

5.94 University of Limerick Company Overview 201

5.94.1 University of Limerick Pipeline Products & Ongoing Clinical Trials Overview 201

5.95 University of Michigan Company Overview 202

5.95.1 University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 202

5.96 University of Rochester Company Overview 203

5.96.1 University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 203

5.97 University of Texas Southwestern Medical Center Company Overview 204

5.97.1 University of Texas Southwestern Medical Center Pipeline Products & Ongoing Clinical Trials Overview 204

5.98 University of Toledo Company Overview 205

5.98.1 University of Toledo Pipeline Products & Ongoing Clinical Trials Overview 205

5.99 University of Vermont Company Overview 207

5.99.1 University of Vermont Pipeline Products & Ongoing Clinical Trials Overview 207

5.100 Vanderbilt University Company Overview 208

5.100.1 Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 208

5.101 Vascoscope BV Company Overview 209

5.101.1 Vascoscope BV Pipeline Products & Ongoing Clinical Trials Overview 209

5.102 Vascudyne Inc Company Overview 210

5.102.1 Vascudyne Inc Pipeline Products & Ongoing Clinical Trials Overview 210

5.103 Vascular Genesis Company Overview 213

5.103.1 Vascular Genesis Pipeline Products & Ongoing Clinical Trials Overview 213

5.104 Verasonics, Inc. Company Overview 214

5.104.1 Verasonics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 214

5.105 Vital Access Corp Company Overview 215

5.105.1 Vital Access Corp Pipeline Products & Ongoing Clinical Trials Overview 215

5.106 Vizio Medical Devices Company Overview 216

5.106.1 Vizio Medical Devices Pipeline Products & Ongoing Clinical Trials Overview 216

5.107 Voyager Biomedical Inc Company Overview 217

5.107.1 Voyager Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 217

5.108 Xeltis AG Company Overview 220

5.108.1 Xeltis AG Pipeline Products & Ongoing Clinical Trials Overview 220

5.109 Xerem Medical Ltd Company Overview 223

5.109.1 Xerem Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 223

5.110 Zylox-Tonbridge Medical Technology Co Ltd Company Overview 224

5.110.1 Zylox-Tonbridge Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 224

6 Renal Dialysis Equipment- Recent Developments 225

6.1 Jun 20, 2023: Breakthrough Study Demonstrates that High-Dose Hemodiafiltration Treatment for Kidney Failure Patients Significantly Reduces Mortality Rates 225

6.2 Jun 09, 2023: Renalytix Reports Financial Results for Third Quarter of Fiscal Year 2023 226

6.3 Jun 05, 2023: Renalytix to Report Third Quarter Fiscal Year 2023 Financial Results on June 9 227

6.4 May 15, 2023: SeaStar Medical reports Q1 2023 financial results and provides a business update 227

6.5 May 12, 2023: Marubun announces summary of consolidated financial results for the fiscal year ended March 31, 2023 229

6.6 May 11, 2023: Medtronic to announce financial results for its fourth quarter and full fiscal year 2023 229

6.7 May 10, 2023: Nephros announces results for quarter ended March 31, 2023 230

6.8 May 09, 2023: Redsense Medical announces interim report Q1 January – March, 2023 231

6.9 May 04, 2023: Teleflex reports first quarter financial results and full year 2023 outlook 232

6.10 Apr 26, 2023: Merit Medical reports results for first quarter March 31, 2023 234

6.11 Apr 20, 2023: Teleflex announces first quarter 2023 earnings conference call information 234

6.12 Apr 12, 2023: Medtronic has a layoff in California 234

6.13 Apr 06, 2023: Merit Medical Systems to Announce First Quarter 2023 Results on April 26, 2023 235

6.14 Apr 03, 2023: Medtronic and DaVita launch new company to focus on kidney health 235

6.15 Mar 29, 2023: Baxter to Host Annual Meeting of Stockholders in Virtual Format 235

6.16 Mar 22, 2023: Renalytix to Report Second Quarter and First Half Fiscal Year 2023 Financial Results on March 30 236

6.17 Mar 16, 2023: Medtronic joins in $25M funding round for home monitoring company 236

6.18 Mar 09, 2023: Somatus expands partnership with Inova to further enhance Care and Improve Outcomes for Patients 236

6.19 Mar 08, 2023: Nephros Announces Fourth Quarter and Fiscal Year 2022 Financial Results 237

6.20 Mar 08, 2023: UCSF Health Appoints Two Prominent Healthcare Executives to Senior Leadership Positions 239

6.21 Mar 08, 2023: Asahi Kasei Corp. Announces Change in Representative Directors 239

6.22 Feb 23, 2023: Teleflex Reports Fourth Quarter and Full Year 2022 Financial Results 239

6.23 Feb 22, 2023: Nephros Fourth Quarter and Fiscal Year 2022 Financial Results Conference Call 243

6.24 Feb 21, 2023: Teleflex to Present at the 44th Annual Raymond James Institutional Investors Conference 244

6.25 Feb 14, 2023: Marubun Notice of Revisions of Consolidated Financial Results Forecast for the Fiscal Year Ending March 31, 2023 and Dividend Forecast 244

6.26 Feb 13, 2023: Rockwell Medical and Concerto Renal Services establish new three-year, multi-million dollar product purchase agreement 244

6.27 Feb 10, 2023: Groundbreaking USask research identifies key blood protein target for improving dialysis 245

6.28 Feb 09, 2023: Teleflex Announces Fourth Quarter 2022 Earnings Conference Call Information 246

6.29 Feb 09, 2023: Baxter Reports Fourth-Quarter and Full-Year 2022 Results 246

6.30 Feb 08, 2023: Asahi Kasei Announces Consolidated Results for 1st to 3rd Quarter Fiscal 2022 249

6.31 Feb 07, 2023: JMS Co Announces Financial Results for the 3rd Quarter of FYE March 2023 249

6.32 Feb 03, 2023: Merit Medical Systems to Announce Fourth Quarter and Year End 2022 Results and Issue Fiscal Year 2023 Guidance on February 22, 2023 250

6.33 Jan 31, 2023: Marubun Corporation Announces Summary of Consolidated Financial Results for the Nine Months Ended December 31, 2022 250

6.34 Jan 25, 2023: Outset Medical to Report Fourth Quarter and Full Year 2022 Financial Results on Monday, February 13, 2023 250

6.35 Jan 20, 2023: Healthcare Workers File Petition Asking FDA to Recall Fresenius Dialysis Machines to Protect Patients 251

6.36 Jan 09, 2023: Outset Medical Reports Expected Fourth Quarter and Full Year 2022 Revenue, Provides 2023 Revenue and non-GAAP Gross Margin Guidance 252

6.37 Jan 09, 2023: Satellite Healthcare Appoints Board of Directors Chair and Vice Chair 253

6.38 Dec 13, 2022: Rockwell Medical Begins Selling its Hemodialysis Concentrates Products to New Clinics in Minnesota with its Largest Customer 253

6.39 Dec 07, 2022: Cook Medical welcomes Dr. John A. Kaufman as Chief Medical Officer 254

6.40 Nov 23, 2022: Medtronic Reports Quarterly Earnings 255

6.41 Nov 22, 2022: Renalytix to Report Financial Results for First Quarter Fiscal Year 2023 on November 30 255

6.42 Nov 22, 2022: Medtronic reports second quarter fiscal 2023 financial results 255

6.43 Nov 22, 2022: Fresenius Places Bonds With a Volume of EUR1 Billion 261

6.44 Nov 15, 2022: Medtronic Set to Announce Earnings on Tuesday 261

6.45 Nov 14, 2022: Rockwell Medical Provides Business Strategy Update and Announces Third Quarter 2022 Financial and Operational Results 261

6.46 Nov 10, 2022: Study examines symptom burden before and after starting dialysis in older adults 263

6.47 Nov 09, 2022: Redsense Medical Interim Report Q3 – July – September, 2022 263

6.48 Nov 09, 2022: Redsense Medical Announces Interim Report Q3 – July – September, 2022 265

6.49 Nov 09, 2022: Asahi Kasei announces Consolidated Results for 1st and 2nd Quarter Fiscal 2022 266

6.50 Nov 04, 2022: JMS Co. Announces Consolidated Financial Highlights for the Interim Period Ended September 2022 266

6.51 Nov 04, 2022: Poly Medicure Announces Unaudited Standalone & Consolidated Financial Results for the Quarter Ended 0n 30th Sep. 2022 267

6.52 Nov 02, 2022: Nephros Announces Results for Quarter Ended September 30, 2022 267

6.53 Oct 31, 2022: Renalytix Reports Full Year Fiscal 2022 Results 269

6.54 Oct 31, 2022: Renalytix Reports Full Year Fiscal 2022 Results 271

6.55 Oct 27, 2022: Teleflex Reports Third Quarter Financial Results And Full Year Outlook 273

6.56 Oct 27, 2022: Satellite Healthcare introduces an innovative care model for people newly diagnosed with kidney disease requiring dialysis 274

6.57 Oct 26, 2022: Outset Medical to Report Third Quarter 2022 Financial Results Tuesday, November 8, 2022 274

6.58 Oct 13, 2022: Teleflex Announces Third Quarter 2022 Earnings Conference Call Information 275

6.59 Oct 13, 2022: Merit Medical Systems to Announce Third Quarter Results on October 26, 2022 275

6.60 Oct 12, 2022: Nephros to Present at LD Micro Main Event XV 275

6.61 Sep 29, 2022: UMC Health System and Dialyze direct collaborate to bring onsite dialysis options to Lubbock County and West Texas 275

6.62 Sep 26, 2022: Satellite Healthcare joins other non-profit partners to open first dialysis center in Hawai‘i focused on higher-risk patients 276

6.63 Sep 26, 2022: Miromatrix CEO Jeff Ross to Present at the Innovations in Solid Organ and Hematopoietic Stem Cell Transplant Virtual Event 277

6.64 Sep 20, 2022: Miromatrix CEO Jeff Ross to Present at the Bioregate European Regenerative Medicine Forum 277

6.65 Sep 15, 2022: New article brings forward support for home dialysis in connection with comorbidities 277

6.66 Sep 07, 2022: Baxter to Host Third-Quarter 2022 Financial Results Conference Call for Investors 278

6.67 Sep 07, 2022: Medtronic to appear at September investor conferences 278

6.68 Aug 30, 2022: Outset Medical to Present at the 20th Annual Morgan Stanley Global Healthcare Conference 278

6.69 Aug 25, 2022: Somatus Names New Medical Executive to Direct the Delivery of World-Class Kidney Care 279

6.70 Aug 23, 2022: Medtronic reports first quarter fiscal 2023 financial results 279

6.71 Aug 23, 2022: Medtronic Announces Quarterly Earnings Results 282

6.72 Aug 17, 2022: Mr. Rom Mendel appointed new CEO of Optinova 285

6.73 Aug 16, 2022: Boston Scientific Announces Upcoming Conference Schedule 285

6.74 Aug 15, 2022: Miromatrix Reports Second Quarter 2022 Results and Provides Corporate Update 285

6.75 Aug 11, 2022: NanoVibronix announce quarter ended June 30, 2022 286

6.76 Aug 10, 2022: Nephros Announces Results for Quarter Ended June 30, 2022 287

6.77 Aug 05, 2022: JMS Co. Announces Consolidated Financial Highlights for the Interim Period Ended June 2022 289

6.78 Aug 04, 2022: Poly Medicure announces Financial results For The Quarter Ended 30Th June 2022 290

6.79 Aug 01, 2022: Outset Medical Reports Second Quarter 2022 Financial Results and Provides 2022 Guidance 291

6.80 Aug 01, 2022: Outset Medical Resumes Shipment of Tablo Systems for Home Use Reports Second Quarter 2022 Financial Results and Provides 2022 Guidance 292

6.81 Aug 01, 2022: Miromatrix to Report Second Quarter 2022 Financial Results 293

6.82 Jul 27, 2022: Merit Medical Reports Results for Quarter Ended June 30, 2022 294

6.83 Jul 27, 2022: Nephros Second Quarter 2022 Financial Results Conference Call 295

6.84 Jul 14, 2022: Merit Medical Systems to Announce Second Quarter Results on July 27, 2022 295

7 Appendix 297

7.1 Methodology 297

7.2 About GlobalData 300

7.3 Contact Us 300

7.4 Disclaimer 300

Table

Renal Dialysis Equipment – Pipeline Products by Stage of Development 23

Renal Dialysis Equipment – Pipeline Products by Segment 24

Renal Dialysis Equipment – Pipeline Products by Territory 25

Renal Dialysis Equipment – Pipeline Products by Regulatory Path 27

Renal Dialysis Equipment – Pipeline Products by Estimated Approval Date 28

Renal Dialysis Equipment – Ongoing Clinical Trials 29

Renal Dialysis Equipment Companies – Pipeline Products by Stage of Development 30

Renal Dialysis Equipment – Pipeline Products by Stage of Development 34

Access Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 38

Dialysis Catheter – Product Status 38

Dialysis Catheter – Product Description 38

Dialysis Port – Product Status 39

Dialysis Port – Product Description 39

Acotec Scientific Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 40

AV Scoring Balloon – Product Status 40

AV Scoring Balloon – Product Description 40

Advanced Dialysis Methods Ltd. Pipeline Products & Ongoing Clinical Trials Overview 41

Vibro-Care – Product Status 41

Vibro-Care – Product Description 41

Advent Access Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 42

av-Guardian – Product Status 42

av-Guardian – Product Description 42

AngioDynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 43

Acuswift – Product Status 43

Acuswift – Product Description 43

Next Generation Dialysis Device – Product Status 44

Next Generation Dialysis Device – Product Description 44

Angiotech Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 45

5-FU Anti-Infective HemoStream Dialysis Catheter – Product Status 45

5-FU Anti-Infective HemoStream Dialysis Catheter – Product Description 45

Aperture Biomedical LLC Pipeline Products & Ongoing Clinical Trials Overview 46

Vascular Access Device – Hemodialysis – Product Status 46

Vascular Access Device – Hemodialysis – Product Description 46

Ariste Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 47

Drug Eluting Tunneled Dialysis Catheter – Product Status 47

Drug Eluting Tunneled Dialysis Catheter – Product Description 47

Ash Access Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 48

MaxFlow – Product Status 48

MaxFlow – Product Description 48

SureFlow – Product Status 49

SureFlow – Product Description 49

Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 50

CWP 800 Mini – Product Status 50

CWP 800 Mini – Product Description 50

Non PVC CAPD – Product Status 51

Non PVC CAPD – Product Description 51

oXiris – Product Status 51

oXiris – Product Description 52

Point of Care Generation 1 System – Product Status 52

Point of Care Generation 1 System – Product Description 52

Point of Care Generation 2 System – Product Status 53

Point of Care Generation 2 System – Product Description 53

PrisMax 2 System – Product Status 53

PrisMax 2 System – Product Description 54

Baxter International Inc – Ongoing Clinical Trials Overview 55

oXiris – A Pilot Multicentre Open-Label Randomized Controlled Trial During Treatment for Acute Kidney Injury in Critically Ill Patients with Septic Shock Comparing Two Haemofilter Membrane Devices, The An69st and the Newly Available Oxiris Haemofiltration Membrane for Early Resolution of Shock As Well As Other Clinical and Technical Performance Outcomes 57

oXiris – A Randomized, Controlled Trial to Evaluate Efficacy and Safety of a Highly Selective Semipermeable Membrane (AN-69 Oxiris) in Comparison with a Semi Selective Semipermeable Membrane (Standard AN-69) in COVID-19 Associated Acute Kidney Injury: oXAKI-COV Study 57

oXiris – Antibiotic Plasma Concentrations During Continuous Renal Replacement Therapy with a High Adsorption Membrane (oXiris) 58

oXiris – Clinical Study of Microcirculatory Parameters in Septic/Septic Shock Patients Treated with Oxiris Filter 59

oXiris – Effect of Oxiris Membrane on Microcirculation Following Cardiac Surgery Under Cardiopulmonary Bypass: A Pilot Prospective Monocentric Study (Oxicard Study) 59

oXiris – Effects of Removal of Endotoxin, Cytokines, and Uremic Toxins Using Blood Purification on Patients with Severe Septic Shock 59

oXiris – Endotoxins and Cytokines Removal During Continuous Hemofiltration with oXiris 60

oXiris – Evaluation of Oxiris Membrane as a Treatment for Ischemia-reperfusion Syndrome in Cardiogenic Shock Treated with Extracorporeal Life Support (ECMO/ECLS): A Randomized Pilot Study ECMORIX 60

oXiris – Real-time Monitoring of Hemodynamic Stability in Septic Shock Patients Undergoing Continuous Renal Replacement Therapy: Propensity Score-matched Comparison Between oXiris and Polysulfone Membranes 60

oXiris – Renal Replacement Therapy with a Cytokine Absorption Filter (oXiris) in Patients with Septic Shock: a Case-control Study Nested in a Cohort 61

oXiris – The Effect of a Hemoperfusion with Polyethyleneimine-coated Membrane Filter (Oxiris) in Patients with Septic Shock: A Multicenter Randomized Controlled Trial 61

oXiris – The Effects of Extracorporeal Blood Purification (oXiris) in Patients with Cardiogenic Shock Requiring VA-ECMO: A Prospective, Open-label, Randomized Controlled Pilot Study 61

oXiris – The Effects of oXiris on Systemic Inflammation, Endothelial Dysfunction and Volume Control in Cardiac Surgery Patients Undergoing Cardiopulmonary Bypass 62

oXiris – The Efficacy of Different Mode of Blood Purification in Septic Children 62

Biosurfaces Inc Pipeline Products & Ongoing Clinical Trials Overview 63

NuSpun Vascular Graft – Product Status 63

NuSpun Vascular Graft – Product Description 63

Bioteque Corp Pipeline Products & Ongoing Clinical Trials Overview 64

Fold-Proof Dialysis Catheter – Product Status 64

Fold-Proof Dialysis Catheter – Product Description 64

BOA Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 65

GARNET Device – Product Status 65

GARNET Device – Product Description 65

BOA Biomedical Inc – Ongoing Clinical Trials Overview 66

GARNET Device – Feasibility of Hemodialysis with the GARNET Device in Chronic Hemodialysis Patients with a Bloodstream Infection 67

Brookhaven Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 68

Hemoaccess Valve System – Product Status 68

Hemoaccess Valve System – Product Description 68

Byonyks Pipeline Products & Ongoing Clinical Trials Overview 69

Robo-Kidney – Product Status 69

Robo-Kidney – Product Description 69

CatheNect Medical Pipeline Products & Ongoing Clinical Trials Overview 70

Peritoneal Dialysis Catheter – Product Status 70

Peritoneal Dialysis Catheter – Product Description 70

Cerovations LLC Pipeline Products & Ongoing Clinical Trials Overview 71

Contamination Resistant Interconnection Device – Product Status 71

Contamination Resistant Interconnection Device – Product Description 71

Chemica Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 72

Portable Hemodialysis System – Product Status 72

Portable Hemodialysis System – Product Description 72

Chrysalis Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 73

Hemodialysis Catheter – Product Status 73

Hemodialysis Catheter – Product Description 73

Columbia University Pipeline Products & Ongoing Clinical Trials Overview 74

Hemodialysis Access Flow Restrictor Device – Product Status 74

Hemodialysis Access Flow Restrictor Device – Product Description 74

CR Bard Inc Pipeline Products & Ongoing Clinical Trials Overview 75

Glidepath LE – Product Status 75

Glidepath LE – Product Description 75

CVS Kidney Care Pipeline Products & Ongoing Clinical Trials Overview 76

HemoCare Hemodialysis System – Product Status 76

HemoCare Hemodialysis System – Product Description 76

CVS Kidney Care – Ongoing Clinical Trials Overview 77

HemoCare Hemodialysis System – An Open Label Study to HemoCare Hemodialysis System for Home Hemodialysis Prior to Market Authorization 78

Cytograft Tissue Engineering Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 79

Lifeline TEBV – AV Shunt – Product Status 79

Lifeline TEBV – AV Shunt – Product Description 79

Debiotech SA Pipeline Products & Ongoing Clinical Trials Overview 80

DialEase – Product Status 80

DialEase – Product Description 80

Renal Expres – Product Status 81

Renal Expres – Product Description 81

Dialco Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 82

DIMI System – Home Use – Product Status 82

DIMI System – Home Use – Product Description 82

Diality Inc Pipeline Products & Ongoing Clinical Trials Overview 83

Dharma – Product Status 83

Dharma – Product Description 83

Diavantis Pipeline Products & Ongoing Clinical Trials Overview 84

Vivaxs Liva – Product Status 84

Vivaxs Liva – Product Description 84

Districlass Medical SA Pipeline Products & Ongoing Clinical Trials Overview 85

DIALCAN – Product Status 85

DIALCAN – Product Description 85

Ellen Medical Devices Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 86

Solar-Powered Dialysis Machine – Product Status 86

Solar-Powered Dialysis Machine – Product Description 86

Ellen Medical Devices Pty Ltd – Ongoing Clinical Trials Overview 87

Solar-Powered Dialysis Machine – A Mixed Methods Early Evaluation Study to Assess The Safety, Efficacy and Usability of a Point of Care Peritoneal Dialysis System When Used By Patients In the Home 88

Emory University Pipeline Products & Ongoing Clinical Trials Overview 89

KIDS CRRT – Product Status 89

KIDS CRRT – Product Description 89

Eqalix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 90

RenalEase – Product Status 90

RenalEase – Product Description 90

ExThera Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 91

Seraph 200 – Product Status 91

Seraph 200 – Product Description 91

Fistulink Ltd. Pipeline Products & Ongoing Clinical Trials Overview 92

Fistulink Device – Product Status 92

Fistulink Device – Product Description 92

Fresenius Medical Care Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 93

Hemodialysis System – Blood Clotting – Product Status 93

Hemodialysis System – Blood Clotting – Product Description 93

Hospital Renal Replacement Device – Product Status 94

Hospital Renal Replacement Device – Product Description 94

Portable Table Top HD Machine – Product Status 94

Portable Table Top HD Machine – Product Description 95

Ultrafiltration Device – Product Status 95

Ultrafiltration Device – Product Description 95

Gambro Dasco SpA Pipeline Products & Ongoing Clinical Trials Overview 96

Artis Dialysis System – Product Status 96

Artis Dialysis System – Product Description 96

Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 97

Disposable Cassette Device – Dialysis – Product Status 97

Disposable Cassette Device – Dialysis – Product Description 97

Pediatric Renal Dialysis Device – Product Status 98

Pediatric Renal Dialysis Device – Product Description 98

Glomeria Therapeutics srl Pipeline Products & Ongoing Clinical Trials Overview 99

DesmoHD – Product Status 99

DesmoHD – Product Description 99

Smart Hemo – Product Status 100

Smart Hemo – Product Description 100

Haemair Ltd Pipeline Products & Ongoing Clinical Trials Overview 101

Extracorporeal Membrane Oxygenation (ECMO) Device – Product Status 101

Extracorporeal Membrane Oxygenation (ECMO) Device – Product Description 101

Healionics Corporation Pipeline Products & Ongoing Clinical Trials Overview 102

STARcuff – Product Status 102

STARcuff – Product Description 102

STARgraft AV+ – Product Status 103

STARgraft AV+ – Product Description 103

STARport – Product Status 103

STARport – Product Description 104

Hemotek Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 105

V-Needle – Product Status 105

V-Needle – Product Description 105

Humacyte Inc Pipeline Products & Ongoing Clinical Trials Overview 106

Humacyl Graft – End Stage Renal Disease – Product Status 106

Humacyl Graft – End Stage Renal Disease – Product Description 106

HumaGraft – Product Status 107

HumaGraft – Product Description 107

Humacyte Inc – Ongoing Clinical Trials Overview 108

HumaGraft – A Phase II Assessment of Humacyte’s Human Acellular Vessel in Patients Needing Vascular Access for Dialysis 109

HumaGraft – A Pilot Study for Evaluation of the Safety and Efficacy of Humacyte’s Human Acellular Vascular Graft as an Above-knee Femoro-popliteal Bypass Graft in Patients with Peripheral Arterial Disease 109

HumaGraft – A Pilot Study for Evaluation of the Safety and Efficacy of Humacyte’s Human Acellular Vascular Graft for Use as a Vascular Prosthesis for Hemodialysis Access in Patients with End-stage Renal Disease 109

Humacyl Graft – End Stage Renal Disease – A Phase 3 Study to Compare the Efficacy and Safety of Humacyte’s Human Acellular Vessel with that of an Autologous Arteriovenous Fistula in Subjects with End Stage Renal Disease 110

Humacyl Graft – End Stage Renal Disease – An Assessment of Humacyte’s Human Acellular Vessel in Patients Needing Renal Replacement Therapy: A Comparison with ePTFE Grafts as Conduits for Hemodialysis: HUMANITY 110

Humacyl Graft – End Stage Renal Disease – Individual Patient Expanded Access for Human Acellular Vessel (HAV) 110

Indian Institute of Technology Bombay Pipeline Products & Ongoing Clinical Trials Overview 111

Dialysis Cuff – Product Status 111

Dialysis Cuff – Product Description 111

Infomed SA Pipeline Products & Ongoing Clinical Trials Overview 112

DIMI Home Hemodialysis Device – Product Status 112

DIMI Home Hemodialysis Device – Product Description 112

DIMI PD System – Product Status 113

DIMI PD System – Product Description 113

Infomed SA – Ongoing Clinical Trials Overview 114

DIMI Home Hemodialysis Device – A Prospective Multicenter, Open Label, Non-randomized, Cross-over Study Evaluating the Use of the DIMI Renal Replacement Therapy (RRT) System In-center by Trained Dialysis Nurses and In-home by Trained Care Partners and Patients with End Stage Renal Disease (ESRD) Who are on Stable Dialysis Regimens 115

InnAVasc Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 116

InnAVasc Arteriovenous Graft Surgical Implant – Product Status 116

InnAVasc Arteriovenous Graft Surgical Implant – Product Description 116

InnAVasc Medical Inc – Ongoing Clinical Trials Overview 117

InnAVasc Arteriovenous Graft Surgical Implant – A Study to Evaluate the Safety and Effectiveness of the Innavasc Arteriovenous Graft for Hemodialysis Access in Patients with End-stage Renal Disease 118

Innovative BioTherapies Inc Pipeline Products & Ongoing Clinical Trials Overview 119

Selective Cytopheretic Device – Product Status 119

Selective Cytopheretic Device – Product Description 119

Selective Cytopheretic Device Gen 2 – Pediatrics – Product Status 120

Selective Cytopheretic Device Gen 2 – Pediatrics – Product Description 120

Katharos, Inc. Pipeline Products & Ongoing Clinical Trials Overview 121

Phosphates Removing Device – Hemodialysis – Product Status 121

Phosphates Removing Device – Hemodialysis – Product Description 121

Koronis Biomedical Technologies Corporation Pipeline Products & Ongoing Clinical Trials Overview 122

Continuous Renal Replacement Therapy Device – Product Status 122

Continuous Renal Replacement Therapy Device – Product Description 122

Kuleana Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 123

Portable Hemodialysis Device – Product Status 123

Portable Hemodialysis Device – Product Description 123

Laminate Medical Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 124

VasQ – Product Status 124

VasQ – Product Description 125

Laminate Medical Technologies Ltd – Ongoing Clinical Trials Overview 126

VasQ – A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula 127

VasQ – Impact of VasQ External Support Device in Maturation and Utilization of Radiocephalic Arteriovenous Fistulas: A Randomized Study 127

LiberDi Ltd Pipeline Products & Ongoing Clinical Trials Overview 128

Intelligent Dialysis Assistant (IDA) – Product Status 128

Intelligent Dialysis Assistant (IDA) – Product Description 128

LiberDi Ltd – Ongoing Clinical Trials Overview 129

Intelligent Dialysis Assistant (IDA) – A Prospective, Open-label, Cross-over, Multi-center Pilot Study to Evaluate the Safety, Feasibility and Usability of the IDA in Subjects Suffering From a Stage 5 Kidney Disease and Who Are Treated With Peritoneal Dialysis 130

Intelligent Dialysis Assistant (IDA) – A Single Arm, Prospective, Open Label, Cross-over, Multi-center Study to Evaluate the Safety, Feasibility and Usability of the Intelligent Dialysis Assistant (IDA) 130

Mar Cor Purification Inc Pipeline Products & Ongoing Clinical Trials Overview 131

Sentri Central Water System – Product Status 131

Sentri Central Water System – Product Description 131

Marvao Medical Devices Ltd Pipeline Products & Ongoing Clinical Trials Overview 132

NexSite Hemodialysis Catheter – Product Status 132

NexSite Hemodialysis Catheter – Product Description 132

Minnesota Health Solutions Corporation Pipeline Products & Ongoing Clinical Trials Overview 133

Dialysis Access Dysfunction Treatment Device – Product Status 133

Dialysis Access Dysfunction Treatment Device – Product Description 133

Mozarc Medical Holding LLC Pipeline Products & Ongoing Clinical Trials Overview 134

HD Multi-Pass System – Product Status 134

HD Multi-Pass System – Product Description 134

HDS – Hemodialysis System – Product Status 135

HDS – Hemodialysis System – Product Description 135

Nanodialysis BV Pipeline Products & Ongoing Clinical Trials Overview 136

Portable Hemodialysis Device – Product Status 136

Portable Hemodialysis Device – Product Description 136

NanoVasc, Inc. Pipeline Products & Ongoing Clinical Trials Overview 137

NanoVasc Polyurethane Graft – Product Status 137

NanoVasc Polyurethane Graft – Product Description 137

Neokidney Development BV Pipeline Products & Ongoing Clinical Trials Overview 138

Neokidney 2.0 – Product Status 138

Neokidney 2.0 – Product Description 138

Nephros Inc Pipeline Products & Ongoing Clinical Trials Overview 139

EndoPur Endotoxin 40” Filter – Product Status 139

EndoPur Endotoxin 40” Filter – Product Description 139

Nicast Ltd Pipeline Products & Ongoing Clinical Trials Overview 140

Improved Version Of The AVflo Vascular Access Graft – Product Status 140

Improved Version Of The AVflo Vascular Access Graft – Product Description 140

Nikkiso Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 141

Artificial Kidneys – Product Status 141

Artificial Kidneys – Product Description 141

Blood Volume Monitor For DCG-03 / DBG-03 – Product Status 142

Blood Volume Monitor For DCG-03 / DBG-03 – Product Description 142

Next Generation Dialysis Machine – Product Status 142

Next Generation Dialysis Machine – Product Description 143

Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 144

SafeTouch Dialysis CATH Plus P – Product Status 144

SafeTouch Dialysis CATH Plus P – Product Description 144

Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 145

Adjustable Banding Device – Product Status 145

Adjustable Banding Device – Product Description 145

Hemodialysis Needle – Product Status 146

Hemodialysis Needle – Product Description 146

Novaflux Technologies Pipeline Products & Ongoing Clinical Trials Overview 147

Outside-In (OI) Dialysis Filter – Product Status 147

Outside-In (OI) Dialysis Filter – Product Description 147

NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 148

NuSpun Central Venous Catheter Cuff – Product Status 148

NuSpun Central Venous Catheter Cuff – Product Description 148

NuSpun Hemodialysis Access Graft – Product Status 149

NuSpun Hemodialysis Access Graft – Product Description 149

NxStage Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 150

Next Generation Critical Care System – Product Status 150

Next Generation Critical Care System – Product Description 150

NxStage System One – Peritoneal Dialysis – Product Status 151

NxStage System One – Peritoneal Dialysis – Product Description 151

Occlutech International AB Pipeline Products & Ongoing Clinical Trials Overview 152

Dialysis Prosthesis Device – Product Status 152

Dialysis Prosthesis Device – Product Description 152

Oxford Biomaterials Ltd Pipeline Products & Ongoing Clinical Trials Overview 153

SpiderGraft – Product Status 153

SpiderGraft – Product Description 153

Padmaseetha Technologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 154

mCAPD – Product Status 154

mCAPD – Product Description 154

Phase One Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 155

Goldilocks Valved Hemodialysis Catheter – Product Status 155

Goldilocks Valved Hemodialysis Catheter – Product Description 155

Reversus Hemodialysis Catheter – Product Status 156

Reversus Hemodialysis Catheter – Product Description 156

Phraxis, Inc. Pipeline Products & Ongoing Clinical Trials Overview 157

Phraxis InterGraft – Product Status 157

Phraxis InterGraft – Product Description 157

Physiologas Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 158

Home Dialysis Machine – Product Status 158

Home Dialysis Machine – Product Description 158

Qidni Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 159

Implantable Renal Replacement Therapy Device – Product Status 159

Implantable Renal Replacement Therapy Device – Product Description 159

Quanta Dialysis Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 160

Advanced Haemodialysis System – Nocturnal Use – Product Status 160

Advanced Haemodialysis System – Nocturnal Use – Product Description 160

Rajamadhangi Medical Technologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 161

Dialysis Cartridge – Product Status 161

Dialysis Cartridge – Product Description 161

Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 162

Peritoneal Dialysis Device – Product Status 162

Peritoneal Dialysis Device – Product Description 162

Redsense Medical AB Pipeline Products & Ongoing Clinical Trials Overview 163

Redsense Clamp – Product Status 163

Redsense Clamp – Product Description 163

RegenMedTX LLC Pipeline Products & Ongoing Clinical Trials Overview 164

Neo-Vessel Replacement – Vascular Access Graft – Product Status 164

Neo-Vessel Replacement – Vascular Access Graft – Product Description 164

Renal Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 165

Dialysate Regeneration System – Peritoneal Dialysis – Product Status 165

Dialysate Regeneration System – Peritoneal Dialysis – Product Description 165

SeaStar Medical Pipeline Products & Ongoing Clinical Trials Overview 166

Selective Cytopheretic Device – Adult Use – Product Status 166

Selective Cytopheretic Device – Adult Use – Product Description 166

Selective Cytopheretic Device – Cardiorenal Syndrome In Congestive Heart Failure (LVAD) – Product Status 167

Selective Cytopheretic Device – Cardiorenal Syndrome In Congestive Heart Failure (LVAD) – Product Description 167

Selective Cytopheretic Device – Cardiorenal Syndrome In Congestive Heart Failure (No LVAD) – Product Status 167

Selective Cytopheretic Device – Cardiorenal Syndrome In Congestive Heart Failure (No LVAD) – Product Description 168

Selective Cytopheretic Device – Hepatorenal Syndrome – Product Status 168

Selective Cytopheretic Device – Hepatorenal Syndrome – Product Description 168

Selective Cytopheretic Device – Myocardial Stunning In End Stage Renal Disease – Product Status 169

Selective Cytopheretic Device – Myocardial Stunning In End Stage Renal Disease – Product Description 169

Selective Cytopheretic Device – Pediatric Use – Product Status 169

Selective Cytopheretic Device – Pediatric Use – Product Description 170

SeaStar Medical – Ongoing Clinical Trials Overview 171

Selective Cytopheretic Device – Adult Use – A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients With Acute Kidney Injury Requiring Continuous Kidney Replacement Therapy 172

Selective Cytopheretic Device – Adult Use – A Pivotal Study to Evaluate the Effectiveness of Selective Cytopheretic Device (SCD) in Patients with Acute Kidney Injury (AKI) 172

Senexis Limited (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 173

Dialysis Related Amyloidosis Device – Product Status 173

Dialysis Related Amyloidosis Device – Product Description 173

Shandong Weigao Blood Purification Products Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 174

4th Generation PP Hemodiafilter – Product Status 174

4th Generation PP Hemodiafilter – Product Description 175

4th Generation PP High-Flux Dialyzer – Product Status 175

4th Generation PP High-Flux Dialyzer – Product Description 175

4th Generation PP Medium-Flux Dialyzer – Product Status 176

4th Generation PP Medium-Flux Dialyzer – Product Description 176

5th Generation Dialyzer – Product Status 176

5th Generation Dialyzer – Product Description 177

6th Generation Dialyzer – Product Status 177

6th Generation Dialyzer – Product Description 177

CRRT Bloodlines – Product Status 178

CRRT Bloodlines – Product Description 178

CRRT Equipment – Product Status 178

CRRT Equipment – Product Description 179

CRRT Filter – Product Status 179

CRRT Filter – Product Description 179

Hemodialysis Machine – Product Status 180

Hemodialysis Machine – Product Description 180

Silmag SA Pipeline Products & Ongoing Clinical Trials Overview 181

Cuffed Or Non-Cuffed Peritoneal Dialysis Catheter – Product Status 181

Cuffed Or Non-Cuffed Peritoneal Dialysis Catheter – Product Description 181

Silicone Hemodialysis Catheter Kit – Product Status 182

Silicone Hemodialysis Catheter Kit – Product Description 182

Simergent LLC Pipeline Products & Ongoing Clinical Trials Overview 183

Archimedes System – Product Status 183

Archimedes System – Product Description 183

Disposable Tubing Set – Product Status 184

Disposable Tubing Set – Product Description 184

Faraday – Product Status 184

Faraday – Product Description 185

Southern Illinois University Carbondale Pipeline Products & Ongoing Clinical Trials Overview 186

Material Retrieval Device – Product Status 186

Material Retrieval Device – Product Description 186

Specialty Renal Products Inc Pipeline Products & Ongoing Clinical Trials Overview 187

Dialysate Regeneration Filter System – Product Status 187

Dialysate Regeneration Filter System – Product Description 187

Second-Generation HDF System – Product Status 188

Second-Generation HDF System – Product Description 188

Stent Tek Ltd Pipeline Products & Ongoing Clinical Trials Overview 189

ePATH AVF Device – Product Status 189

ePATH AVF Device – Product Description 189

TEI Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 190

Biologic Vascular Graft – Product Status 190

Biologic Vascular Graft – Product Description 190

Thorn Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 191

Neocare Peritoneal Dialysis Machine – Product Status 191

Neocare Peritoneal Dialysis Machine – Product Description 191

Triomed AB Pipeline Products & Ongoing Clinical Trials Overview 192

Carry Life Renal – Product Status 192

Carry Life Renal – Product Description 192

Carry Life UF – Product Status 193

Carry Life UF – Product Description 193

Triomed AB – Ongoing Clinical Trials Overview 194

Carry Life UF – A Clinical Study With the Carry Life UF System in Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients 195

University of Arizona Pipeline Products & Ongoing Clinical Trials Overview 196

Percutaneous Vascular Anastomosis Device – Dialysis – Product Status 196

Percutaneous Vascular Anastomosis Device – Dialysis – Product Description 196

University of California Pipeline Products & Ongoing Clinical Trials Overview 197

Smart Dialysis Catheter – Product Status 197

Smart Dialysis Catheter – Product Description 197

University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 198

iHemo Dialysis System – Product Status 198

iHemo Dialysis System – Product Description 198

Implantable Device – Percutaneous AVF – Product Status 199

Implantable Device – Percutaneous AVF – Product Description 199

University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 200

Nanocomposite Material Vascular Graft – Product Status 200

Nanocomposite Material Vascular Graft – Product Description 200

University of Limerick Pipeline Products & Ongoing Clinical Trials Overview 201

Prolong AV Graft – Product Status 201

Prolong AV Graft – Product Description 201

University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 202

Cold Dialysate Regeneration System – Product Status 202

Cold Dialysate Regeneration System – Product Description 202

University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 203

Nanoporous Membrane Based Hemodialyzer – Product Status 203

Nanoporous Membrane Based Hemodialyzer – Product Description 203

University of Texas Southwestern Medical Center Pipeline Products & Ongoing Clinical Trials Overview 204

PercSac – Product Status 204

PercSac – Product Description 204

University of Toledo Pipeline Products & Ongoing Clinical Trials Overview 205

Triple D Urology Catheter – Product Status 205

Triple D Urology Catheter – Product Description 205

Urinary Catheter – Product Status 206

Urinary Catheter – Product Description 206

University of Vermont Pipeline Products & Ongoing Clinical Trials Overview 207

Weighted Peritoneal Dialysis Catheter Anchor – Product Status 207

Weighted Peritoneal Dialysis Catheter Anchor – Product Description 207

Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 208

Hemocartridge – Product Status 208

Hemocartridge – Product Description 208

Vascoscope BV Pipeline Products & Ongoing Clinical Trials Overview 209

Vascoscope – Hemodialysis – Product Status 209

Vascoscope – Hemodialysis – Product Description 209

Vascudyne Inc Pipeline Products & Ongoing Clinical Trials Overview 210

TRUE Vascular Graft – Hemodialysis – Product Status 210

TRUE Vascular Graft – Hemodialysis – Product Description 210

Vascudyne Inc – Ongoing Clinical Trials Overview 211

TRUE Vascular Graft – Hemodialysis – Initial Safety Study of the TRUE AVC in Hemodialysis Access (TRUE AVC I Study) 212

Vascular Genesis Pipeline Products & Ongoing Clinical Trials Overview 213

The Vascular Genesis AVs – Product Status 213

The Vascular Genesis AVs – Product Description 213

Verasonics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 214

Transcutaneous Ultrasound Device – Product Status 214

Transcutaneous Ultrasound Device – Product Description 214

Vital Access Corp Pipeline Products & Ongoing Clinical Trials Overview 215

Venous Window Access Device – Product Status 215

Venous Window Access Device – Product Description 215

Vizio Medical Devices Pipeline Products & Ongoing Clinical Trials Overview 216

Ambulatory Wearable Device – Product Status 216

Ambulatory Wearable Device – Product Description 216

Voyager Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 217

ARK – Product Status 217

ARK – Product Description 217

Voyager Biomedical Inc – Ongoing Clinical Trials Overview 218

ARK – Pivotal Voyager Ark Device Vascular Access Study 219

Xeltis AG Pipeline Products & Ongoing Clinical Trials Overview 220

Xeltis Hemodialysis Vascular Access Graft – Product Status 220

Xeltis Hemodialysis Vascular Access Graft – Product Description 220

Xeltis AG – Ongoing Clinical Trials Overview 221

Xeltis Hemodialysis Vascular Access Graft – First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft (aXess) 222

Xeltis Hemodialysis Vascular Access Graft – Prospective, Non-randomized Pivotal Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft: aXess Pivotal Study 222

Xerem Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 223

Hemodialysis Implant – Product Status 223

Hemodialysis Implant – Product Description 223

Zylox-Tonbridge Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 224

Second Generation High Pressure PTA Balloon Catheter – Product Status 224

Second Generation High Pressure PTA Balloon Catheter – Product Description 224

Glossary 299

Figures

Renal Dialysis Equipment – Pipeline Products by Stage of Development 23

Renal Dialysis Equipment – Pipeline Products by Segment 24

Renal Dialysis Equipment – Pipeline Products by Territory 25

Renal Dialysis Equipment – Pipeline Products by Regulatory Path 27

Renal Dialysis Equipment – Pipeline Products by Estimated Approval Date 28

Renal Dialysis Equipment – Ongoing Clinical Trials 29

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